Executive Director, Quality Operations

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The Head of Quality Operations will direct all aspects of Quality Operations including Process Quality Assurance and Analytical Quality within Ardelyx. This role will provide strategic direction to the Quality Process and Quality Analytical teams, lead GMP batch review, disposition, CMO deviations and change management programs for API, drug product and finished goods, and support development projects.

• Demonstrate a primary commitment to patient safety and product quality by maintaining compliance to Ardelyx Quality Policies and procedures
• Support the development of a proactive quality systems culture throughout the business
• Establish a high‑performing team to drive organizational goals and instill a robust quality culture
• Drive engagement to ensure personnel have clear expectations, appropriate tools, and opportunities for growth and recognition
• Ensure adequate investigations into OOT/OOS results generated at contract test labs
• Ensure compliance with post‑market requirements for annual stability testing of designated batches
• Partner with Technical Operations and Regulatory Affairs on development projects, method and process transfer/optimization, and validation program requirements
• Establish data trending programs across products to proactively identify and investigate trends
• Drive systemic process change as a result of deviations/investigations and other quality trends
• Help define department objectives to align with corporate goals
• Keep management informed on product quality and other concerns such as supplier quality issues and deviations
• Assure appropriate systems for assessing product impact, investigation, follow‑up and closure of deviations and audit observations
• Sponsor quality and technical projects with third‑party suppliers, collaborating with internal stakeholders and GxP partners to facilitate resolution of quality and technical issues
• Evaluate and approve compliance documentation including regulatory filings for Ardelyx products
• Collaborate with Ardelyx international business partners as needed
• Develop budget forecasts and track QA expenses

• Bachelor’s degree with 15+ years of related experience, preferably in life sciences with a minimum of ten years of Quality Assurance and Analytical experience in development and commercial programs
• Must have strong expertise in US FDA regulations and guidance with a strong emphasis on compliance and direct experience with regulatory submissions
• Experience with hosting, leading and managing US regulatory agency inspections preferred
• Strong analytical skills including trend and statistical analysis
• Demonstrated ability to communicate and interact with all levels of the organization including Executive Leadership
• Strong interpersonal skills to provide coaching, training, and direction
• Proven experience influencing across the organization to improve product or processes
• Proven ability to identify Quality issues/discrepancies through a risk‑based approach and effectively and proactively resolve the issues/discrepancies in a diplomatic, flexible and constructive manner
• Knowledge of Regulations, 21
  
  CFR 210/211, ICH Guidelines
• Must be able to manage shifting priorities to meet critical deadlines in a fast‑paced and dynamic environment
• Must have strong written and communication skills
• Ability to travel domestically and internationally up to 15%

Newark, CA

The anticipated annualized base pay range for this full‑time position is $270,000-$330,000. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements.

Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks of living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual winter holiday shut down, and at least 11 paid holidays.

Ardelyx is an equal opportunity employer.